Kornimate/medical-research-clean huggingface dataset:
study to evaluate safety, tolerability, pharmacokinetics, and efficacy of evixapodlin (formerly gs-4224) in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the primary objectives of this study are to characterize the safety and tolerability of evixapodlin (formerly gs-4224) and to determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d) of evixapodlin in participants with advanced solid tumors.

this was a planned phase 1/2 study. however, phase 2 was not conducted because the study was closed due to sponsor decision prior to opening the dose expansion cohort and hence, rp2d analysis was not performed.

Eligibility criteria:
key inclusion criteria: * dose escalation cohorts: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. * dose expansion and 1000 mg twice a day (bid) dose escalation cohorts: individuals must have available sufficient and adequate formalin fixed tumor sample preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of advanced disease has been made and from a site not previously irradiated. alternatively, individuals must agree to have a biopsy taken prior to entering the study to provide adequate tissue. for the 1000 mg bid dose escalation cohort, individuals with melanoma, merkel cell, microsatellite instability-high (msi-h) cancers, and classical hodgkin lymphoma (chl) are not required to have archival or fresh biopsy tissue. * dose escalation biopsy substudy and 1000 mg bid dose escalation cohorts: documented ligand 1 of programmed cell death protein 1 (pd-l1) expression in the tumor (tumor proportion score (tps) ≥ 10% or combined positive score (cps) ≥ 10). in the 1000 mg bid cohort, pd-l1 expression will not be required for merkel cell, melanoma, msi-h cancers, and chl. * eastern cooperative oncology group (ecog) performance status of ≤ 2. * adequate organ function. key exclusion criteria: * history or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion. * dose escalation cohorts: history of ≥ grade 3 adverse events (aes) during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to aes. * dose escalation 1000 mg bid and dose expansion cohort: prior treatment with an immune checkpoint inhibitor (anti-pd-1, anti-pd-l1, or anti- ligand 2 of programmed cell death protein 1 (pd-l2) antibodies). * history of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, wegener's granulomatosis, sjögren's syndrome, bell's palsy, guillain-barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis). note: other protocol defined inclusion/exclusion criteria may apply.
emergency department apneic oxygenation versus usual care during rapid sequence intubation

Conditions: Diffuse Apneic Oxygenation

Summary: to determine the impact, if any the application of oxygen during the apnea period of rapid sequence intubation has on patients being intubated in the emergency department.

hypoxia may occur during rapid sequence intubation (rsi) of emergency department patients (1-4). this condition may increase the risk of the patient suffering a cardiac arrest secondary to securing the airway. a part of rsi is pre-oxygenation, which is defined as placing the patient on 100% fraction of inspired o2 for 3 minutes prior to administering the induction agents (i.e. sedative and neuromuscular blocker) in order to increase the amount of oxygen present in the functional residual capacity of the patients lungs to prolong oxygen saturating during the apneic period of endotracheal intubation (5-9). in the last decade, physicians have developed a process known as diffuse apneic oxygenation (dao) in order to mitigate the risk of oxygen desaturation during this apneic period. the process entails leaving the patient on high flow nasal cannula (hfnc) oxygen during the act of visualizing the vocal cords and placing the endotracheal tube. over the years the practice has started to become more common in emergency departments, operating rooms and icu's all over the world. recently, a randomized controlled trial (called the fellow trial) of this practice demonstrated no difference in desaturation rates between those patients that received dao and those that did not (usual practice) in patients in the icu (10). some have commented that the findings of this study cannot be applied to emergency department patients, and so evidence is lacking in regards to this population. purpose of the study: although studies have started to investigate the efficacy of dao in preventing desaturation during rsi, evidence is still lacking in the emergency department patient population. the primary question being asked is: does diffuse apneic oxygenation increase the average lowest arterial oxygen saturation during rapid sequence intubation when compared to usual care? secondary question being asked is: does diffuse apneic oxygenation decrease the incidence of desaturation in general, as well as hypoxemia and severe hypoxemia? the third question being asked is: does diffuse apneic oxygenation increase the time to desaturation?

Eligibility criteria:
inclusion criteria: any patient greater than 18 years of age that presents to the lincoln medical and mental health center emergency department requiring endotracheal intubation. exclusion criteria: patients will be excluded from the primary outcome analysis, but included in the intention to treat analysis for the secondary outcome if they are not pre-oxygenated to the standard rsi protocol of 3 minutes with 100% fraction of inspired oxygen (fio2) by means of bag valve mask, hfnc and/or non-rebreather; patients will be excluded from the study in general if they are in cardiac or traumatic arrest or they are intubated without an apneic period (awake intubation)
partial rebreathing in the treatment of migraine with aura

Conditions: Migraine With Aura

Summary: a study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain


Eligibility criteria:
inclusion criteria: * - migraine with aura * attack frequency of between one and six migraine-with-aura attacks per month over the last six months * adults (18-60 years) * age at onset of migraine \< 50 years * if taking migraine prophylactic drugs, the dosis must have been stable for \> 3 months * must speak and understand danish exclusion criteria: * - cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease * chronic migraine, i.e. more than 15 headache days per month over the last three months * medication overuse headache * more than six migraine-with-aura attacks per month * non-migraine headache on more than six days per month * a typical duration between migraine-with-aura attacks of less than 48 hours
effects of a range of naltrexone doses in combination with smoked marijuana

Conditions: Marijuana Use

Summary: the purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (\ 50 mg) of naltrexone.

laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related. we have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone (50 mg) enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol (thc), while a low naltrexone dose (12 mg) blunted the effects of thc. a better understanding of the effects of a range of naltrexone doses in combination with smoked marijuana has important implications for the following reasons: (1) alcohol- and opioid-dependent patients receive high doses of naltrexone (50-150 mg), which may increase the abuse liability of marijuana, (2) low-dose naltrexone blunts thc's intoxicating effects, suggesting potential utility as a treatment medication for marijuana dependence. this study will determine if naltrexone (0, 12, 25, 50, 100 mg) administration 45 min prior to marijuana administration (0, 3.27% thc) alters marijuana's subjective, cognitive or physiological effects. marijuana smokers will spend approximately 5h/day for a total of 10 days in the outpatient laboratory. participants will visit the outpatient laboratory 2-3 times per week, with a minimum 48-hr interval between sessions to allow for naltrexone clearance. these data will provide important information regarding the clinical use of naltrexone.

Eligibility criteria:
inclusion criteria: * current marijuana use * able to perform study procedures * 21-45 years of age * women practicing an effective form of birth control exclusion criteria: * current, repeated illicit drug use (other than marijuana) * presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ecg, mantoux test lfts \> 3x upper limit of normal) * history of heart disease * request for drug treatment * current parole or probation * pregnancy or current lactation * recent history of significant violent behavior * previous adverse reaction to naltrexone * major current axis i psychopathology psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia) * current use of any prescription or over-the-counter medication

Keywords: naltrexone smoked marijuana
extracorporeal carbon dioxide removal in severe chronic obstructive pulmonary disease exacerbation

Conditions: COPD Exacerbation

Summary: the conventional treatment for severe acute exacerbation of chronic obstructive pulmonary disease including noninvasive respiratory support, invasive respiratory support, etc, but there are many kinds of limitations and complications. extracorporeal carbon dioxide removal is a life support technology, which can effectively remove co2. recently some clinical studies have showed that ecco2r can effectively improve the aecopd patient's respiratory failure, avoid intubation and removal of endotracheal intubation. we performed a study to evaluate the clinical effectiveness of ecco2r in the treatment of aecopd patients.

with the development of technology, ecco2r is not difficult to implement in intensive care unit. many recently clinical studies have showed that ecco2r can effectively remove co2, reduce patient breathing work, improve the patient respiratory failure, and avoid endotracheal intubation. but there are also treated failure and high incidence of complications such as bleeding in the aecopd patients with ecco2r treatment, and the treatment related to airway management are less mentioned. therefore, we set a more strict inclusion criteria in aecopd patients and evaluate the clinical effectiveness and associated risk of ecco2r in the treatment of aecopd.

Eligibility criteria:
inclusion criteria: * nppv treatment failure: 1. deterioration or no improvement after treatment with nppv, ph \ 70mmhg 2. obvious respiratory distress, rr \> 30 times/min 3. breathing extreme fatigue exclusion criteria: * older than 75 years * endotracheal intubation or tracheostomy * obviously a lot of pus yellow phlegm, expectorate difficult * chest ct: obviously a wide range of consolidation * bmi \< 20 kg/m2, * dysfunction of other organ of extrapulmonary * serious hemodynamic instability * severe hypoxemia, pao2 / fio2 \< 100mmhg * home noninvasive positive pressure ventilation for a long time * lung fungal infection * contraindication of anticoagulation * platelet \< 80000 per cubic millimeter * serum creatinine \> 200 umol/l * cardiac arrest * hospice care * refused to take part in the study

Keywords: copd exacerbation severe ecco2r invasive mechanical ventilation
characterization of the profile of dysarthria in huntington's disease, using the clinical evaluation battery of dysarthria

Conditions: Dysarthria; Huntington Disease

Summary: huntington's disease is a hereditary disease of rare autosomal dominant transmission, both neurodegenerative and neuro-psychiatric. clinically, there are motor symptoms (chorea), cognitive disorders (dementia) and psychiatric disorders. among motor disorders, dysarthria is a commonly found symptom. this is classically referred to as hyperkinetic dysarthria according to the criteria of darley's classification. however, this old classification (1969) is only based on perceptual analysis and lack of specificity. moreover, in the course of the disease, chorea (control of the striatal attack d2) decreases to give place to a parkinsonian syndrome (control of the striatal attack d1) and the dysarthria also evolves towards a hypokinetic form . it also seems likely that cerebellar involvement (responsible for ataxia) contributes to dysarthria. no studies have been published to date to characterize dysarthria in huntington's disease in a quantified, objective and specific manner. however, canan ozsancak describes choreic dysarthria as heterogeneous according to the patients and variable according to the productions. a perceptual study reports an imprecision of the consonants, a lengthening of the pauses, a variable flow, an absence of modulation of the pitch and a hoarse voice. finally, few patients are cared for in speech therapy and there is no specific rehabilitation strategy: this would require - and justify a more precise study of the dysarthria of these patients. the clinical evaluation of dysarthria developed by pascal auzou and véronique rolland-monnoury is a recent and partially standardized tool, combining qualitative and quantitative evaluation, which seems adapted to try to better characterize the dysarthria in huntington's disease.


Eligibility criteria:
inclusion criteria: * diagnosed patients hd * major patients * french-speaking patients * mms score greater than 20 * patients with informed consent signed * patients covered by a social insurance system exclusion criteria: * patients with intercurrent pathologies or other psychiatric disorders that may interfere with battery replacement (at the discretion of the investigator) * illiteracy * persons placed under safeguard of justice (adults under guardianship or guardianship) or deprived of their liberty
combination of oral fludarabine, mitoxantrone und rituximab induction therapy and rituximab maintenance therapy in follicular b-cell lymphoma

Conditions: Follicular T-NHL Lymphoma; Rituximab Maintenance

Summary: immunotherapy with the monoclonal anti-cd20 antibody rituximab has become standard of care for patients with follicular lymphoma. however, there are still open questions regarding dosing and scheduling of rituximab, optimal type of chemotherapeutic combination partners during induction as well as the best interval and length of rituximab maintenance treatment. fludarabine-mitoxantrone combinations have shown strong debulking activity as initial therapy followed by rituximab maintenance. while rituximab maintenance with a standard dose of 375 mg/m2 prolongs clinical remissions, administration schedules still vary: three-monthly infusions for 2 years and two-monthly infusions for one or 2 years are most frequently used. a few pharmacokinetic data for rituximab have been reported for induction treatment. these studies have proposed a presumptive "active" level of 25.000 ng/ml in anti-lymphoma treatment. however, there is only limited information regarding maintenance treatment in patients who are in remission and have no remaining tumor load. the aim of this trial is to investigate the effect of treatment with oral fludarabine, mitoxantrone und rituximab and rituximab maintenance on the depth of remission measured by bcl2/igh pcr.


Eligibility criteria:
inclusion criteria: * a positive bcl2/igh rearrangement in peripheral blood (pb) and/or bone marrow (bm) * clinical stage iii or iv, requiring treatment with one or more of the following criteria: symptoms related to the disease, hemoglobin less than 12 g/dl, platelets less than 100 g/l, progressive disease, bulky tumor of more than 10 cm exclusion criteria: * pretreatment

Keywords: agmt nhl
early assessment of impaired cardiac function in patients with diabetes mellitus

Conditions: Diabetes Mellitus; Left Ventricular Dysfunction

Summary: this is a single-center, prospective, observational study to explore the clinical features and risk factors of impaired cardiac function detected by two-dimensional speckle tracking echocardiography in patients with diabetes mellitus. the risk factors include traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones, and novel serum biomarkers.

cardiovascular complications are a leading cause of death in patients with diabetes mellitus. however, early cardiovascular disease screening presents several challenges, particularly for those who have no cardiovascular symptoms. novel imaging techniques, such as tissue doppler imaging and speckle tracking echocardiography, allow for the more frequent detection of early subclinical left ventricular systolic dysfunction in asymptomatic patients with diabetes. based on speckle tracking echocardiography and other techniques, this study evaluated cardiovascular function in diabetic subjects to achieve the following objectives: a) investigate the clinical characteristics of diabetic patients with early cardiovascular function impairment. b) investigate the role of traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones in diabetic patients with early cardiovascular function impairment. c) explore novel biomarkers of early cardiovascular dysfunction in diabetic patients.

Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥18 and ≤80 years. 2. diagnosed type 2 or type 1 diabetes exclusion criteria: 1. moderate or severe valvular heart disease, history of thoracic surgery or congenital heart disease，atrial fibrillation. 2. history of coronary heart disease or stroke 3. typical symptoms of cardiovascular disease（angina pectoris or limiting dyspnoea (\>nyha ii)） 4. lvef \<60％ 5. malignant tumor, acute infection, abnormal liver and kidney function (alt \> normal upper limit 3 times or egfr \< 60 ml/min/1.73 m2) 6. diabetic ketoacidosis 7. pregnancy

Keywords: diabetes mellitus left ventricular dysfunction
contrast (can contrast injection better approximate ffr compared to pure resting physiology?)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (ffr). reference ffr will be measured using standard adenosine. we hypothesize that contrast ffr will offer superior diagnostic agreement compared to resting conditions.

we are conducting a diagnostic accuracy study. the reference standard is adenosine-derived ffr. the diagnostic tests undergoing evaluation are resting conditions and hyperemia induced by intracoronary injection of contrast medium. while all these tests give a continuous result, we will apply binary cutoffs for comparison to ffr≤0.8 as the reference standard. subjects will be selected prospectively from consecutive patients undergoing ffr assessment for standard clinical indications. the paired comparative design means that each patient will undergo resting (baseline), post-contrast, and adenosine-derived measurements. to enhance test integrity, all pressure recordings will be analyzed in a central physiology core laboratory blinded to clinical data and recruiting site.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * undergoing ffr assessment for standard clinical indications. * ability to understand and willingness to sign a written informed consent. exclusion criteria: * prior coronary artery bypass grafting (cabg). * extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. operators may exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by pressure wire placement. * known severe left ventricular hypertrophy (septal wall thickness at echocardiography of \>13 mm). * inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker). * recent (within 3 weeks prior to cardiac catheterization) st-segment elevation myocardial infarction (stemi) in any arterial distribution (not specifically target lesion). * culprit lesions (based on clinical judgment of the operator) for either stemi or non-stemi cannot be included. * severe cardiomyopathy (ejection fraction \<30%). * renal insufficiency such that an additional 12 to 20 ml of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.

Keywords: fractional flow reserve, myocardial adenosine contrast media
citicholine-amantadine trial in traumatic brain injury

Conditions: Intensive Care Unit

Summary: this randomized study aims at comparing between the effects of amantadine, citcholine and its combinations on arousal and behavioral consequences in early phase of moderate traumatic brain injury (tbi).

as both agents amantadine and citcholine showed considerable effects on neuro-recovery from tbi, the investigators hypothesized that combination therapy of both drugs will have significant effect as it simultaneously will target multiple mechanisms of injury. so, this randomized study aims at comparing between the effects of amantadine, citcholine and their combinations on arousal and behavioral consequences in early phase of moderate tbi

Eligibility criteria:
inclusion criteria: * sustained moderate non-penetrating tbi with gcs of 9-12 exclusion criteria: * patients with mild (gcs \> 12) or severe tbi (gcs \< 9) * patients suffering from any central nervous system disability prior to the traumatic brain injury * major medical problems as; major cardiovascular disease or heart failure, renal insufficiency (creatinine clearance, less than 60 ml per minute), liver impairment, * pregnancy, * more than one seizure in the previous month, * prior treatment with amantadine, * allergy to the study drugs.
brain structural abnormalities in patients with post-covid-19 headache

Conditions: COVID-19; Headache; MRI

Summary: introduction: the clinical manifestations of the covid-19 pandemic are heterogeneous and may include various symptoms (gastrointestinal, musculoskeletal, neurological). approximately 25% of patients report headache as a neurological symptom, making it the fifth most common symptom. these headaches may arise from structural brain changes associated with the infection. purpose: this study aims to identify the structural abnormalities observed in brain mri that correlate with chronic headaches in patients who had covid-19 infection. methods: the study included 30 patients with post-covid-19 headaches and 30 control patients with no history of covid-19. demographic characteristics were analyzed using t-tests and chi-square tests. mri findings were categorized into six types: cortical atrophy, white matter lesions, vascular lesions, lacunar lesions, vascular encephalopathy, and sinusitis. differences in mri findings between the two groups were evaluated using chi-square tests. secondary outcomes included the analysis of symptoms accompanying headaches, diagnoses following mri, and treatments applied.


Eligibility criteria:
inclusion criteria: * age ≥18 years * history of covid-19 infection * persistent headache following covid-19 infection * brain mri requested by the attending physician exclusion criteria: * prior neurological disease or disorder * mri contraindications (e.g., pacemaker, metal implants, claustrophobia)

Keywords: covid-19 headache mri brain white matter lesion